Apparatus, System and Method for Facilitating Tracking of Consumable Pharmaceutical Articles

ABSTRACT

Embodiments of an apparatus, system and method for facilitating the tracking of consumable pharmaceutical articles are disclosed. A marking apparatus is configured to apply unique indelible identifiers to pharmaceutical articles at the point-of-sale. The indelible identifiers on the articles are visually or electronically readable to allow each respective article to be traced with respect to its manufacturer, prescribing physician, patient to whom it was prescribed, dispensing location, expiration date, dosage, or some combination thereof. An associated system and method may involve the provision of a remote database element configured to be in network communication between the marking apparatus, manufacturer, distributor, prescriber, dispensing location, scanning tool, or some combination thereof. The indelible identifier may initially be generated by the apparatus and then obtained and recorded by the remote database element. Alternative, the indelible identifier may initially be generated and recorded by the remote database element, then provided to the marking apparatus.

RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.62/636,819 filed Feb. 28, 2018, and U.S. Provisional Application No.62/714,089 filed Aug. 3, 2018, the contents of each of which areincorporated by this reference in their entireties for all purposes asif fully set forth herein.

TECHNICAL FIELD

The present disclosure relates to facilitating the tracking of the chainof custody of individual consumable articles. More particularly, thepresent disclosure relates to an apparatus, system and method forapplying unique identifiers to individual pharmaceutical articles at apoint of sale.

BACKGROUND

The opioid overdose crisis has reached epidemic levels. Nearly half ofall opioid deaths involved prescription opioids. More people currentlydie from overdoses than they do from guns and cars. What is needed arenew, more effective, cost-effective solutions for fighting the growingopioid crisis.

SUMMARY

Certain deficiencies of the prior art are overcome by the provision ofembodiments of a new apparatus, system and method for implementationpartially or entirely within a pharmaceutical point-of-sale location.Such apparatus, system and method involve application of indelibleidentifiers onto, for example, tablets and capsules at the point of saleor dispensation (e.g., pharmacies and clinics). Examples of indelibleidentifiers may include, for example, text, bar codes, an image of thepatient's face, an RFID tag, a combination thereof or the like. Thistechnology allows unique identifiers to be applied on eachpharmaceutical article (e.g., pill, tablet or capsule) at the time it isdispensed, without damaging the originally-manufactured article, therebyproviding for prescription and patient traceability, and a tool to helpcurb drug counterfeiting and drug overdose. Preferably, imprinting aunique identification (e.g., patient name, prescription number, etc.) oneach opioid dosage, could allow local and federal law enforcement,through the use of a database, to identify and trace each prescriptionback to the original patient and their prescribing doctor.

BRIEF DESCRIPTION OF THE DRAWINGS

Further advantages of the present invention may become apparent to thoseskilled in the art with the benefit of the following detaileddescription of the preferred embodiments and upon reference to theaccompanying drawings in which:

FIG. 1 is a diagrammatic perspective view of one non-limiting example ofa portable point-of-sale marking apparatus in accordance with thepresent disclosure, wherein all or portions of the control electronicsand network communication element are disposed externally of theenclosure;

FIG. 2 illustrates various non-limiting examples of discreet consumablepharmaceutical articles with indelible identifiers in accordance withthe present disclosure;

FIG. 3 is a diagrammatic perspective view of one non-limiting example ofa tray element with pockets in accordance with the present disclosure;

FIG. 4 is a diagrammatic perspective view of one non-limiting example ofa tray element in accordance with the present disclosure beingtransported between a loading position and an application position;

FIG. 5 is a diagrammatic partial front view of the apparatus of FIG. 1,wherein the tray element is shown in an application position;

FIG. 6 is a diagrammatic cross-sectional side view of anothernon-limiting example of a portable point-of-sale marking apparatus inaccordance with the present disclosure, wherein the control electronicsand network communication element are disposed internally of a unitaryenclosure, and the apparatus is shown in electrical communication with apatient camera and a remote database;

FIG. 7 is a schematic view of one non-limiting example of a system andmethod for facilitating tracking of consumable pharmaceutical articlesin accordance with the present disclosure;

FIG. 8 is a diagrammatic partial cross-sectional side view of onenon-limiting example of an apparatus in accordance with the presentdisclosure, wherein the tray element includes a funnel portion and isupwardly-rotatable with respect to a shuttle element;

FIG. 9 is a diagrammatic partial cross-sectional side view similar tothat of FIG. 8, but wherein the tray element is shown transported to theloading position by way of the shuttle element;

FIG. 10 is a diagrammatic partial cross-sectional side view similar tothat of FIG. 9, but wherein the tray element is shown in anupwardly-rotated position thereby enabling consumable articles to betransported from respective pockets to a funnel portion by way ofgravity;

FIG. 11 is a diagrammatic plan view taken along direction 11 of FIG. 10;

FIG. 12 is a diagrammatic partial cross-sectional side view of onenon-limiting example of an apparatus in accordance with the presentdisclosure, wherein the transport subsystem includes a shuttle elementslidable with respect to the enclosure and configured to releasablysupport the tray element, and the transport subsystem includes a springelement for resiliently biasing the shuttle element toward placing thetray element in the loading position;

FIG. 13 is a diagrammatic partial cross-sectional view similar to thatof FIG. 12, but wherein the shuttle element is shown in an extendedposition so as to place the tray element in the loading position, andthe removability of the tray element from the shuttle element isillustrated;

FIG. 14 is a diagrammatic partial cross-sectional top view of onenon-limiting example of an apparatus in accordance with the presentdisclosure; wherein the shuttle element is rotatable with respect to theenclosure in turntable fashion to move the tray element between theloading position and the application zone;

FIG. 15 is a diagrammatic side view of one non-limiting example of atray element in accordance with the present disclosure, wherein the trayelement is a pre-packaged blister pack housing a plurality of consumablearticles in hermetically-sealed configuration, at least one side of theblister pack having a translucent or transparent layer through which theindelible identifier application is achievable without compromising thehermetic seal;

FIG. 16 is a diagrammatic cross-sectional view of one non-limitingexample of a consumable article in accordance with the presentdisclosure, comprising a layer of digestible material deposited onto aprecursor OEM-manufactured pharmaceutical article by way of an apparatusin accordance with the present disclosure;

FIG. 17 is a diagrammatic cross-sectional view of another non-limitingexample of a consumable article in accordance with the presentdisclosure, wherein the article is a precursor OEM-manufacturedpharmaceutical article encapsulated with a respective sensor sleeve byway of a presently-disclosed apparatus, the sensor sleeve having asensor imbedded therein;

FIG. 18 is a diagrammatic cross-sectional view of a further non-limitingexample of a consumable article in accordance with the presentdisclosure, wherein the article is a precursor OEM-manufacturedpharmaceutical article with one or more layers of a marking substratecomposition deposited onto the article by way of a presently-disclosedapparatus;

FIG. 19 is a diagrammatic perspective view of one non-limiting exampleof a randomized article marking system in accordance with the presentdisclosure;

FIG. 20 is a diagrammatic cross-sectional view of portions of theexample marking system of FIG. 19;

FIG. 21 is a diagrammatic top view of an inspection camera a field ofview of a randomized article marking system in accordance with thepresent disclosure, such as the system of FIG. 19, wherein anyoverlapping articles in the application zone have been detected and thenagitated to become non-overlapping;

FIG. 22 is a diagrammatic top view of an inspection camera field of viewsimilar to that of FIG. 21, but wherein the application zone isilluminated in such a way as to produce hotspots which may undesirablyhinder accurate detection of the shapes of each of the articles withinthe application zone;

FIG. 23 is a diagrammatic top view of an inspection camera field of viewsimilar to that of FIG. 22, but wherein the application zone isilluminated without hotspots (e.g., by way of diffused lights, filters,and/or software tools) in order to facilitate accurate identification ofthe shape of each article within the application zone;

FIG. 24 is a diagrammatic top view of a portion of an inspection camerafield of view similar to that of FIG. 22, but wherein a software processis used to find an origin and orientation of each article within theapplication zone; and

FIG. 25 is a diagrammatic flow chart of one example implementation of amethod for facilitating tracking of consumable pharmaceutical articlesin accordance with the present disclosure.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to the drawings, like reference numerals designateidentical or corresponding features throughout the several views.

With reference to the several drawings, a portable point-of-sale markingapparatus 100 for applying indelible identifiers 106 onto discreetconsumable pharmaceutical articles 104 may comprise an enclosure 108, atransport subsystem 110, an identifier application subsystem 112 and aninspection element 114.

The transport subsystem 110 may have a tray element 116 transportablebetween a loading position (see, for example, FIG. 9) and an applicationposition (see, for example, FIG. 8). Referring to FIGS. 3, 4, 8 and 9the tray element 116 may have a multiplicity of pockets 118 eachconfigured to receive a respective said article 104, wherein (a) whenthe tray element 116 is in the application position (see, for exampleFIG. 6), its pockets 118 are located within an application zone 120internal to the enclosure 108, and (b) when the tray element 116 is inthe loading position (see, for example, FIG. 4), its pockets 118 arelocated externally to the enclosure 108. With reference to FIG. 6, theidentifier application subsystem 112 may be positioned within theenclosure 108 for applying an indelible identifier 106 onto each saidarticle 104 within the application zone 120. The inspection element 114may be positioned within the enclosure 108 and may be configured toverify the quality of the indelible identifier 106 applied onto eachrespective article 104. The inspection element 114 may be, or mayinclude, an inspection camera.

Referring to FIGS. 6 and 19, in certain preferred embodiments of theapparatus 100 and system 200, the identifier application subsystem 112may include a transmission element 122 (e.g., a laser transmissionelement) configured to direct a steered beam 124 (e.g., of UV laserenergy) toward the application zone 120 for marking an indelible image106 onto each said article 104 within the application zone 120. Theidentifier application subsystem 112 may further include a beam opticselement 182 optically disposed between the laser transmission element122 and a beam scanning element 180. Control electronics 186 may beprogrammed to control and receive data from some or all of theelectronic components of the apparatus 100, such as the lasertransmission element 122, beam scanning element 180 and inspectionelement 114. A debris vacuum hose 184 may be in debris-evacuatingcommunication between the application zone 120 and the ambientenvironment external to the enclosure 108.

Referring to FIG. 6 for example illustration, in particular embodimentsof the apparatus 100, the enclosure 108 may be unitary, meaning it maydefine a single cavity within which all of the components of theapparatus 100 are housed. The cavity may or may not be partitioned, forexample, to provide internal mounting structures or airflow channels.Moreover, the enclosure may include a lift handle portion 218 tofacilitate movement of the apparatus 100 within the point-of-salelocation 102 by, for example, one person.

Referring to FIGS. 1, 5 and 6 for example illustration, in certainembodiments of the apparatus 100, the transport subsystem 110 mayinclude a handle portion 188 by which the tray element 116 is manuallytransportable between the loading position and the application position.

Referring to FIGS. 8-10 and 12-14 for example illustration, inparticular embodiments of the apparatus 100, the transport subsystem 110may include a shuttle element 126 slidable with respect to the enclosure108 and configured to releasably support the tray element 116.

Referring to FIG. 6 for example illustration, the apparatus 100 mayinclude a tray identification reader 128, and the tray element mayinclude a tray identification element 130 readable by the trayidentification reader 128. In this or other embodiments of the apparatus100 or system 200, the apparatus or system may include a plurality oftray elements 116. In such case, the pockets 118 of each of saidplurality of tray elements 116 may have a different size (e.g., width,length, diameter or a combination thereof) compared to the pockets 118of the other tray elements 116 in the same plurality.

Referring to FIGS. 8 and 9, the shuttle element 116 may be axiallyslidable with respect to the enclosure 108. Such axial slidability maybe along a slide axis 190. Referring to FIGS. 12 and 13 for exampleillustration, the transport subsystem 110 may include a spring element134 for resiliently biasing the shuttle element 126 toward placing thetray element 116 in the loading position. The transport subsystem 110may include a latch element 136 for releasably retaining the trayelement 116 in the application position. Alternatively, or in addition,as illustrated in FIG. 14 for example, the shuttle element 126 may berotatable with respect to the enclosure 108 in turntable fashion so asto transport one or more tray elements 116 into and out of theapplication zone 120.

Referring to FIGS. 8-11 for example illustration, in certain preferredembodiments of the portable, point-of-sale marking apparatus 100, (a)the tray element 116 includes a funnel portion 138; (b) the tray element116 is upwardly-rotatable with respect to the shuttle element 126 whenreleasably supported thereby; and (c) the upward rotation 140 isconfigured to enable consumable articles 104 to be transported fromrespective said pockets 118 to the funnel portion 138 by way of gravity.In such an apparatus embodiment, the tray element 116 may include arotation handle element 142 to manually facilitate the upward rotation.

Referring to FIG. 6 for example illustration, in certain preferredembodiments of the apparatus 100, the enclosure 108 may include anapplication zone window portion 144 disposed between the applicationzone 120 and the loading position. The application zone window portion144 may be configured to enable a naked eye of a human to view theoccurrence of the application (e.g., involving transmission of laserenergy) from a viewpoint 146 outward of the enclosure 108 withoutcausing damage to the eye.

Referring to FIGS. 6 and 7 for example illustration, particularpreferred embodiments of the apparatus 100 may further comprise anetwork communication element 148 configured to be placed in networkcommunication with a remote database element 150. The remote databaseelement 150 may be configured to be in data-receiving communicationswith a pharmaceutical manufacturer 176 or distributor 176, therebycollectively forming an embodiment of a tracking system 178 inaccordance with the present disclosure. Alternatively, or in addition,the remote database element 150 may be placed (or configured to beplaced) in network communication with a law enforcement scanning tool156, thereby collectively forming an alternate embodiment of a system178 in accordance with the present disclosure. Such scanning tool 156may be configured to read the indelible identifier 106 and indicatewhether the indelible identifier corresponds to the patient to whom therespective article was legitimately prescribed and sold.

The indelible identifier 106 may include article identifier data uniqueto the article 104 upon which it is applied. The article identifier datamay include patient data for identifying a patient 220 to whom therespective article was prescribed and sold. Alternatively, or inaddition, the article identifier data may include prescriber data foridentifying a prescriber 132 by whom the respective article wasprescribed. Alternatively, or in addition, the article identifier datamay include prescription data for identifying the prescription numberunder which the respective article was sold.

Referring to FIGS. 6 and 16, certain embodiments of the apparatus 100may further comprise a layer-depositing element 158 for depositing oneor more layers 160 of digestible material into the articles 104. The oneor more layers 160 may be configured to indicate whether and when thearticles 104 have been consumed by a patient.

Referring to FIGS. 6 and 17, the identifier application subsystem 112may include a sleeve-encapsulation element 162 for encapsulating each ofthe articles 104 with a respective sensor sleeve 164, the sensor sleeves164 each having a sensor 166 imbedded therein.

Referring to FIG. 6, the identifier application subsystem 112 mayinclude a marking layer applicator 168 by which the indelible identifier106 is applied onto each said article within the application zone.Referring to FIG. 18, the marking layer applicator 168 may be configuredto deposit one or more layers of a marking substrate composition 170onto each said article 104 within the marking zone 120. The markingsubstrate composition 170 may comprise, for example, Titanium Dioxide orthe like. The deposition may be by way of, for example, a sprayingoperation. Referring to FIG. 6, the identifier application subsystem 112may include a laser transmission element 122 configured to direct asteered beam 124 of UV laser energy toward the application zone 120 formarking an indelible image 106 onto the marking substrate composition170 deposited onto each said article within the application zone 120.

Referring to FIG. 2 for example illustrations, the indelible identifiers106 may be or include optically-viewable indelible images. In such case,each indelible image may include a facial image 172 of the respectivepatient 220 to whom the article was prescribed. Moreover, referring toFIG. 6, in such embodiment, the apparatus 100 may include or beconfigured to be placed in communication with a patient camera subsystem174 for obtaining the facial image 172 at the point-of-sale location102.

In particular embodiments of the apparatus, the indelible identifier 106may include an RFID tag and the inspection element 114 may include anRFID reader.

In particular embodiments of the a portable, point-of-sale markingapparatus 100, (a) the discrete consumable articles 104 are defined aseach comprising a precursor electrically-conductive layer prior tocoming into contact with the apparatus 100; and (b) the applicationsubsystem 112 includes a laser transmission element 122 configured todirect a steered beam of laser energy 124 toward the application zone120 for (i) marking an indelible image 106 onto each said article withinthe application zone 120; and (ii) etching into the precursorelectrically-conductive layer to form an RFID tag.

Referring to FIG. 15 for example illustration, in particular embodimentsof the portable, point-of-sale marking apparatus 100, the tray element116 may be or include an original equipment manufactured (OEM)pre-packaged blister back housing a plurality (e.g., an array) of saidarticles 104 in hermetically-sealed configuration, at least one side ofthe blister pack having a translucent or transparent layer 192 throughwhich the indelible identifier application is achievable withoutcompromising (e.g., breaking) the hermetic seal. In such an embodiment,the transport subsystem 110 may also include a shuttle element 126slidable with respect to the enclosure 108 and configured to releasablysupport the tray element (e.g., as shown in FIG. 13).

Referring to FIG. 7, a system and method in accordance with the presentdisclosure may facilitate or comprise a series of steps. By way of anon-limiting example, a manufacturer 176 of pharmaceutical articles(e.g., opioid drugs) may supply the drug information (e.g.,manufacturing date, lot, expiration date, shipping date, etc.) to thedatabase element 150. The database element 150 may also receiveinformation from any distribution point between the manufacturer 176 andthe point-of-sale 102 (e.g., dispensing pharmacy or clinic). This stepmay operate, for example, similarly to a conventional courier trackingsystem. When the pharmacy 102 fills the prescription for a specificpatient, that pharmacy may upload all the relevant data (e.g.,prescribing physician 132 and patient names, addresses, drug quantity,etc.) into the same database element 150. The dispensing pharmacy 102may then use the apparatus 100 to mark every solid dosage form (e.g.,article 104) with a unique indelible identifier 106 linked to(associated with) the prescription. Referring to FIG. 2, such indelibleidentifier 106 may be, for example, a picture, a 2D code, analphanumerical code, a cipher or any other combination of visible and/orinvisible information (e.g., RFID). The dispensing pharmacy may thenupload the identifier into the database element 150, thereby completingthe cycle. The method may include an option for an automated subprocesswhereby, for example, a prescribing physician enters a prescription intothe database which randomly generates the UNIQUE ID, and the pharmacythen uses the apparatus 100 to mark this ID on every tablet/capsulewhile filling the prescription. Finally, the end user (e.g., patient) orother authorized personnel (e.g., nurse in the hospital, policemen onthe street) can scan the tablet ID with an appropriate scanning device156 (e.g., a cell phone) in network communication with the databaseelement 150 and can determine what solid dosage form is underconsideration and what it is intended for (e.g. date of manufacture,point of sale, physician and patient names, expiration date, etc.).

In one alternate embodiment of the method, the need for a database andscanning device may be eliminated and the dispensing pharmacy can justprint, for example, a picture ID on each tablet. Other intermediatescenarios with incomplete or just local (e.g. hospital) databases arealso possible. Notably, a database element 150 as described herein maycomprise one or more processor elements, and one or more correspondingdatabase components or memory storage devices, each of which may belocated geographically remotely from one another.

With reference to FIGS. 19 and 20, one or more of the portablepoint-of-sale marking apparatuses 100 in accordance with the presentdisclosure, or larger production-scale marking apparatuses with some orall of the same features and components as the portable version, may beconfigured to incorporate a randomized article marking system 200 inwhich a plurality of articles 104 can be randomly placed on the trayelement 116 (e.g., by hand or by hopper mechanism) having a traycoordinate system 202, and then analyzed and marked by the system 200 insitu (i.e., without requiring the articles to be organized in an orderedarray prior to marking). Once a plurality of articles 104 are placed onthe tray element 116, an inspection camera 114 may obtain a firstinspection image of the marking zone 120 within its field of view 206.The preliminary inspection image may then be analyzed (e.g., via one ormore software modules) to determine various characteristics of thearticles 104. By way of example, referring to FIG. 24, for each article104 present within the marking field 120, the first inspection image(e.g., the image shown in FIG. 23) may be used assign a unique articleidentifier (e.g., alphanumeric) to each article 104 present within themarking zone 120, and to determine the respective article's X-Y position210, angular orientation 212 (e.g., within the X-Y plane), shape, size,color and/or texture. These characteristics may then be stored as uniquearticle datasets (e.g., in a dataset storage memory element), whereineach article dataset corresponds to a different article 104 within themarking zone 120 during the same inspection/marking cycle. The articledataset may then be used to produce a field marking image (e.g., by wayof a respective marking image software module) to determine where andhow the marking beam 124 should be activated and steered within themarking zone 120 in order to apply the proper markings (e.g., by way oflaser transmission element 122, beam optics element 182, and beamscanning element 180) to each respective article 104. Finally, theinspection camera 114 may be configured to obtain a second inspectionimage to verify that each of the articles within the marking zone 120were correctly marked and that the number of marked articles presentwithin the applications/marking zone 120 (i.e., a batch) are counted.This article count may be recorded in a memory element configured to bein communication with or forming part of the control electronics 186.Additionally, or in the alternative, the article count may be recordedin a memory element configured to be in communication with or formingpart of the remote database 150. Moreover, depending upon the particularembodiment of the apparatus 100, the inspection camera 114 may beconfigured or directed (i.e., by the control electronics 186) to obtaina count of the total number of articles 104 present within theapplication/marking zone 120, before, during and/or after the marking ofall of the articles 104 present in the application/marking zone 120 hasoccurred. The apparatus 100 may be configured such that the articlecount corresponding to a particular batch of articles 104 may be printedonto a container in which the batch of marked articles will be placedfor storage within the pharmacy or dispensing to the patient or thepatient's care facility.

Referring to FIGS. 19 and 20, embodiments of a randomized articlemarking system 200 may include one or more agitation elements 204 toensure that none of the articles within the marking zone 120 overlap.Such agitation elements 204 may include, for example, a laterally-movingor circularly-moving blade or brush configured to sweep over thearticles at a pre-determined height, or (as shown in FIG. 20) avibration element 204 for momentarily vibrating the tray element 116. Inparticular embodiments of the system 200, these agitation elements maybe employed as a matter of course regardless of whether an overlappingof the articles 104 has initially been detected. Alternatively, or inaddition, embodiments of the system 200 may be configured to obtain apreliminary inspection image (e.g., preceding the first inspection imagementioned above) to determine any of the articles 104 in the markingzone 120 appear to be overlapping with another article 104 (see, e.g.,overlapping/elevated article 104 a). If it is determined thatoverlapping has or may have occurred, agitation element 204 may then beactivated. A post-agitation image may also be obtained in order toverify that no instances of overlapping remain (see, e.g., FIG. 21)within the marking zone 120. A lateral boundary wall 214 may be providedto retain the articles on the tray 116 during, for example, agitation.The boundary wall be an integral part of the tray 116, or may be aseparate component positioned in proximity to the periphery of the tray116.

Referring to FIG. 23, in certain embodiment of a randomized articlemarking system 200, the application/marking zone 120 may be illuminatedby a field illumination element 208. In order to limit or preventhotspots from being introduced in the image when the first inspectionimage is obtained (for example, the hotspot shown at 216 in FIG. 22),the illumination element 208 may include diffused lights, filters,and/or software tools, in order to facilitate accurate identification ofthe shape of each article 104 within the application zone. Referring toFIG. 24, a software process may be used to determine an X-Y origin 210and orientation 212 of each article 104 within the application zone.

Notably, preferred embodiments of a randomized article marking system200 may be configured to mark multiple different shapes and types ofarticles within the same marking or application zone 120 during the sameinspection/marking cycle. By way of example, the system 200 may becapable of using the first inspection image to identify pharmaceuticaltablets 104 of different types based on their shape, color and/ortexture. This information may then be compared to a database (internalor external to the system 200) to allow the system 200 to identify thepharmaceutical composition of the respective tablets 104. Thispharmaceutical composition information may then be used as a factor incontrolling what indelible identifier 106 is marked into the respectivearticle 104.

Referring to FIGS. 7 and 25, particular preferred embodiments of amethod 250 for facilitating tracking of consumable pharmaceuticalarticles 104 are disclosed herein. For example, at block 252, a remotedatabase element 150 may be provided which is configured to be innetwork communication with a marking apparatus 100 located in apharmaceutical dispensary 102. The pharmaceutical dispensary 102 may bea point-of-sale location at which the patient is dispensed theprescribed quantity of articles 104 (e.g., a pharmacy or hospital).

At block 254, a remote database element 150 may acquire drug informationpertaining to each of a manufactured quantity of consumablepharmaceutical articles. At block 256, the remote database element 150may receive prescription data defined by a prescription issued from aprescriber 132 to a respective patient. This prescription data mayinclude, for example, (a) a prescription quantity defining the number ofsaid consumable pharmaceutical articles prescribed to the respectivepatient; and (b) a patient identifier (e.g., the patient's name)uniquely corresponding to the respective patient. In certain embodimentsof the method, the step of receiving may be by way of networkcommunication between the prescriber 132 and the remote database element150. The prescription quantity of articles would typically comprise asubset of the manufactured quantity of articles.

At block 258, the remote database element 150 may record a digital imageof an indelible identifier 106 applied by way of the marking apparatus100 to each of the consumable pharmaceutical articles 104 in theprescription quantity. The digital image may preferably be recorded incorrespondence with some or all of the prescription data. In certainembodiments of the method, the digital image may be generated by themarking apparatus 100 and obtained by the remote database element 150prior to the step of recording. Notably, the digital image may be, forexample, a graphical reproduction of the indelible identifier (e.g., asraster or vector image data) or some other optically-readable orsignal-readable data format that informationally mirrors the indelibleidentifier.

The indelible identifier 106 may be configured to be readable by ascanning tool 156 configured to thereby display some or all of theprescription data associated with the respective consumablepharmaceutical article 104. The indelible identifier 106 may preferablybe an alpha-numeric code, photo image (e.g., the face of the patient), abar code, a QR code, a cipher, an RFID code some combination thereof orthe like. The indelible identifier 106 is preferably uniquely associatedwith the respective prescription.

The drug information may include one or more of the following:manufacturing date, a lot number, an expiration date and a shippingdate. The drug information may be acquired from a distributor ormanufacturer 176 of the manufactured quantity by way of networkcommunication with the remote server element 150.

The prescription data may further include one or more of the following:name of the prescriber 132, name of the patient 220, address of thepatient, location of the pharmaceutical dispensary, prescription number,article dosage (e.g., strength) and article expiration date.

In particular preferred embodiments of the method, prior to the step ofrecording, the remote database element 150 may generate the digitalimage. The remote database element 150 may then provide the digitalimage to the marking apparatus 100 for application of the indelibleidentifier onto or within the articles 104.

In certain preferred embodiments of the method, the remote databaseelement 150 may be configured to be placed in network communication withthe scanning tool 156 to thereby provide the prescription data to thescanning tool for the display of the prescription data.

While embodiments of the invention have been illustrated and described,it is not intended that these embodiments illustrate and describe allpossible forms of the invention. Rather, the words used in thespecification are words of description rather than limitation, and it isunderstood that various changes may be made without departing from thespirit and scope of the invention.

1. A portable, point-of-sale marking apparatus for applying indelibleidentifiers onto discreet consumable pharmaceutical articles, theapparatus comprising: an enclosure; a transport subsystem configured totransport a tray element between a loading position and an applicationposition, the tray element having a multiplicity of pockets eachconfigured to retain a respective said article, wherein (a) when thetray element is in the application position, its pockets are locatedwithin an application zone internal to the enclosure, and (b) when thetray element is in the loading position, its pockets are locatedexternally to the enclosure; an identifier application subsystempositioned within the enclosure for applying an indelible identifieronto each said article within the application zone; and an inspectionelement positioned within the enclosure and configured to verify thequality of the indelible identifier applied onto each respectivearticle.
 2. A portable, point-of-sale marking apparatus as defined inclaim 1, wherein the identifier application subsystem includes a lasertransmission element configured to direct a steered beam of UV laserenergy toward the application zone for marking an indelible image ontoeach said article within the application zone.
 3. A portable,point-of-sale marking apparatus as defined in claim 1, wherein theenclosure is unitary.
 4. (canceled)
 5. A portable, point-of-sale markingapparatus as defined in claim 1, wherein the transport subsystemincludes a shuttle element slidable with respect to the enclosure andconfigured to releasably support the tray element.
 6. A portable,point-of-sale marking apparatus as defined in claim 5, wherein theapparatus includes a tray identification reader, and the tray elementincludes a tray identification element readable by the trayidentification reader.
 7. A portable, point-of-sale marking apparatus asdefined in claim 6, wherein the apparatus includes a plurality of trayelements, the pockets of each of said plurality of tray elements havinga different size compared to the pockets of the other tray elements.8-13 (canceled)
 14. A portable, point-of-sale marking apparatus asdefined in claim 1, wherein the enclosure includes an application zonewindow portion disposed between the application position and the loadingposition, the application zone window portion being configured to enablea naked eye of a human to view the occurrence of the application from aviewpoint outward of the enclosure without causing damage to the eye.15. A portable, point-of-sale marking apparatus as defined in claim 1further comprising a network communication element configured to beplaced in network communication with a remote database.
 16. A portable,point-of-sale marking apparatus as defined in claim 1, wherein theindelible identifier includes article identifier data unique to thearticle upon which it is applied.
 17. A portable, point-of-sale markingapparatus as defined in claim 16, wherein the article identifier dataincludes patient data for identifying a patient to whom the respectivearticle was prescribed and sold.
 18. A portable, point-of-sale markingapparatus as defined in claim 16, wherein the article identifier dataincludes prescriber data for identifying a prescriber by whom therespective article was prescribed.
 19. A portable, point-of-sale markingapparatus as defined in claim 16, wherein the article identifier dataincludes prescription data for identifying the prescription number underwhich the respective article was sold.
 20. A portable, point-of-salemarking apparatus as defined in claim 15, wherein the remote database isin data-receiving communications with a pharmaceutical manufacturer ordistributor.
 21. A portable, point-of-sale marking apparatus as definedin claim 15, wherein the remote database is in network communicationwith a law enforcement scanning tool, the scanning tool being configuredto read the indelible identifier and indicate whether the indelibleidentifier corresponds to the patient to whom the respective article wasprescribed and sold.
 22. A portable, point-of-sale marking apparatus asdefined in claim 1 further comprising a layer-depositing element fordepositing one or more layers of digestible material onto the articles,the one or more layers being configured to indicate whether and when thearticles have been consumed by a patient.
 23. A portable, point-of-salemarking apparatus as defined in claim 1 wherein the identifierapplication subsystem includes a sleeve-encapsulation element forencapsulating each of the articles with a respective sensor sleeve, thesensor sleeves each having a sensor imbedded therein.
 24. A portable,point-of-sale marking apparatus as defined in claim 1 wherein saididentifier application subsystem includes a marking layer applicator bywhich the indelible identifier is applied onto each said article withinthe application zone.
 25. A portable, point-of-sale marking apparatus asdefined in claim 24 wherein the marking layer applicator is configuredto deposit one or more layers of a marking substrate composition ontoeach said article within the marking zone, the marking substratecomposition comprising Titanium Dioxide.
 26. A portable, point-of-salemarking apparatus as defined in claim 25 wherein the deposition is byway of a spraying operation.
 27. A portable, point-of-sale markingapparatus as defined in claim 25 wherein the identifier applicationsubsystem includes a laser transmission element configured to direct asteered beam of UV laser energy toward the application zone for markingan indelible image onto the marking substrate composition deposited ontoeach said article within the application zone.
 29. A portable,point-of-sale marking apparatus as defined in claim 1 wherein theinspection element is an inspection camera.
 30. A portable,point-of-sale marking apparatus as defined in claim 1 wherein theindelible identifiers are or include optically-viewable indelibleimages.
 31. A portable, point-of-sale marking apparatus as defined inclaim 30 wherein each indelible image includes a facial image of therespective patient to whom the article was prescribed.
 32. A portable,point-of-sale marking apparatus as defined in claim 31 wherein theapparatus is configured to be placed in communication with a patientcamera subsystem for obtaining the facial image.
 33. A portable,point-of-sale marking apparatus as defined in claim 1 wherein theindelible identifier includes an RFID tag and the inspection elementincludes an RFID reader.
 34. A portable, point-of-sale marking apparatusas defined in claim 1 wherein (a) the discrete consumable articles aredefined as each comprising a precursor electrically-conductive layerprior to coming into contact with the apparatus; and (b) the identifierapplication subsystem includes a laser transmission element configuredto direct a steered beam of laser energy toward the application zone for(i) marking an indelible image onto each said article within theapplication zone; and (ii) etching into the precursorelectrically-conductive layer to form an RFID tag.
 35. A portable,point-of-sale marking apparatus as defined in claim 1, wherein the trayelement is a pre-packaged blister back housing a plurality of saidarticles in hermetically-sealed configuration, at least one side of theblister pack having a translucent or transparent layer through which theindelible identifier application is achievable without compromising thehermetic seal. 36-67. (canceled)